Medical Device Regulatory Specialist

2 weeks ago


Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time
{"Qualifications and Responsibilities": "

We are looking for a skilled Medical Device Regulatory Specialist to join our Clinical and Regulatory team. The ideal candidate will have a strong background in quality assurance and regulatory affairs, with a focus on medical devices.

The successful candidate will possess a master's degree in a relevant field and have experience working with quality management systems and regulatory requirements within MDR and ISO 13485. They will also have excellent communication skills in English and the ability to work independently and as part of a cross-functional team.

The role will involve assisting management in prioritizing regulatory approval activities, reviewing and revising QMS procedures, and coordinating product submissions. The candidate will also participate in audits and training of the company in QMS procedures.

Key responsibilities will include:

  1. Co-driving product release projects in collaboration with the project manager from the development team
  2. Supporting other departments in design control
  3. Leading risk analysis for new products, with support from the clinical and development team
  4. Reviewing and revising QMS procedures to ensure efficiency and effectiveness
  5. Assisting management in prioritizing regulatory approval activities based on strategy and market potentials
  6. Creating and coordinating product submissions for the devices we develop
  7. Training the company in QMS procedures
  8. Participating in audits, both internal and external

We offer a dynamic and collaborative work environment, with opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

", "About Radiobotics": "

Radiobotics is a mission-driven company dedicated to solving the global need for radiologists. Our vision is to make routine X-rays of the musculoskeletal system accessible to non-specialists, ensuring patients receive expert-level care.

We strive to learn beyond the surface, pursue big ideas, and engage in a playful and curious work environment. If you share our values and are passionate about quality and regulatory affairs, we would love to hear from you.

", "How to Apply": "

If you are a motivated and experienced professional looking for a new challenge, we encourage you to submit your application, including your resume and a cover letter, to [insert contact information]. We look forward to hearing from you.

"}

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